Issue

ISPE to work on implementation docs for ICH Q8 and Q9 guidelines

ISPE recently announced that it will collaborate with FDA to facilitate the implementation of the new quality guidelines (Q8 and Q9) developed by the International Conference on Harmonization (ICH).

Following ISPE’s Annual Meeting in Orlando, Florida, last November, representatives from ISPE’s Regulatory Affairs Committee (RAC) met with Dr. Moheb Nasr of FDA’s Center for Drug Evaluation and Research (CDER) and Joe Famulare of FDA CDER/Compliance to discuss a vision and roadmap for implementation of the ICH Q8 and Q9 guidelines.

The ISPE is planning a workshop, which will be held June 6-7, 2007, at the Crystal Gateway Marriott in Alexandria, Virginia. It will include FDA participation to discuss the issues and gain industry input on the initiative.

According to a press release, Paul D’Eramo, Johnson & Johnson’s Executive Director for Quality and Compliance Worldwide and Chair of ISPE’s Regulatory Affairs Committee, said, “This initiative will have a significant impact for companies interested in FDA’s offer to provide regulatory flexibility by providing new ways to file drug applications, supplements, and implement modern quality systems. We strongly encourage all professionals working in these areas to attend the workshop and provide their input.”